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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K902464
Device Name CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITY
Applicant
Chartermed, Inc.
70 Oberlin Ave. N.
Lakewood,  NJ  08701
Applicant Contact ALICE PREVILLE
Correspondent
Chartermed, Inc.
70 Oberlin Ave. N.
Lakewood,  NJ  08701
Correspondent Contact ALICE PREVILLE
Regulation Number880.5025
Classification Product Code
KPE  
Date Received06/04/1990
Decision Date 08/30/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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